Effect of 6 Weeks Daily Consumption of a Cereal-based Juice Beverage on Gastrointestinal Health (NEWDRINK)

December 11, 2017 updated by: Professor Lars Ove Dragsted, University of Copenhagen

The project is a randomized, 2-way, blinded parallel trial in which 56 healthy adults of both genders with frequent occurrence of stomach trouble.This intervention trial with 6 weeks of daily intake β-glucans will be carried out with a beverage containing β-glucans and a control beverage without β-glucans. The primary aim is to investigate whether β-glucans from barley has an effect on stomach and intestinal health, including stool volume and frequency. Microbiota, concentrations of short chain fatty acids (butyrate, propionate, acetate), calprotectin, and energy and fat content in feces. Furthermore, blood pressure and exhaled hydrogen and methane, before and after the intervention, subjective perception of gastrointestinal problems and digestion as well as the participants' attitudes towards functional foods are measured using Visual Analog Scale (VAS).

Further, specific metabolites of β-glucans in urine (exploratory endpoint) and certain toxic metabolites from the microbiota using metabolite profiling (metabolomics) are also analyzed

Study Overview

Detailed Description

β-glucans from barley slows gastric emptying rate and prolongs the transit time of food in the small intestine." The relatively undigested β-glucans have the ability to increase satiety and stimulate digestion, ensuring regular bowel movements and relieve sluggish bowel movements, including constipation and constipation. β-glucans are fermented down in the large intestine, resulting in production of short-chain fatty acids which inhibit the biosynthesis of cholesterol, hence blood cholesterol levels are lowered (not the goal here). Subsequently, β-glucans may also affect blood pressure. As a direct result of the effects in the intestine, there will be an improvement in the quality of life for people with stomach upsets and maybe a reduction in the risk of cardiovascular disease.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Frederiksberg, Denmark, 1958
        • Department of Nutrition, Exercise and Sports, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 20 - 27 kg/m2
  • Like test and control drink, pasta, meat sauce as these foods are part of the test meal.
  • Healthy subjects sometimes or often bothered by mild gastric problems such as bloating, loose stools or constipation
  • Willing to handle in 2 x 3-day total feces at the start and end of the study

Exclusion Criteria:

  • Suffering from irritable bowel syndrome (IBS), bacterial overgrowth in the small intestine (SIBO) or inflammatory bowel disease (IBD).
  • Systemic infections, psychiatric or metabolic diseases, and any clinical condition
  • Chronic or frequent use of medication (including blood thinners, excluding contraceptives)
  • Frequent loose stools
  • Blood donations during or in the month leading up to the study period
  • Elite athletes (> 10 hours of hard exercise / week, self-reported)
  • High intake of alcohol (defined as a weekly intake of > 7 units for women and > 14 units for men),
  • Have or have had a drug addiction
  • Participation in other scientific studies during the study period
  • Lactating
  • Pregnancy or ongoing planning of pregnancy
  • Vegetarianism or veganism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test drink
Test drink: Barley β-glucan
The test beverages with Barley β-glucan is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks. Subsequent were a full dose of the test drinks consumed for 5 weeks. In total was the test drinks consumed for 6 weeks.
Other Names:
  • barley beta-glucan beverages
Placebo Comparator: Control drink
Control drink: barley beverage
The control beverages is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks. Subsequent were a full dose of the test drinks
Other Names:
  • barley drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool volume
Time Frame: 0 and 6 weeks
Changes in total stool weight 2 x 3 days from 72 hours before study start and 72 hours before study termination after 6 weeks, determined by a mixed model analysis.
0 and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydrogen
Time Frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Changes in exhaled hydrogen concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.
0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Methane
Time Frame: 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Changes in exhaled methane concentrations determined by a mixed model analysis and subsequently at each time point with 0 as a co-variate.
0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Hydrogen Area Under the Curve
Time Frame: -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Area Under the Curve (AUC) for exhaled hydrogen
-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Methane Area Under the Curve
Time Frame: -2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Area Under the Curve (AUC) for exhaled methane
-2, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 and 360 min
Fecal concentrations of SCFA
Time Frame: 0 and 6 weeks
Changes in SCFA concentrations determined by a mixed model analysis
0 and 6 weeks
Determination and variations in fecal microbiota
Time Frame: 0 and 6 weeks
Changes in microbiota determined by a mixed model analysis
0 and 6 weeks
Fecal concentrations of calprotectin
Time Frame: 0 and 6 weeks
Changes in calprotectin concentrations determined by a mixed model analysis
0 and 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic profile in 24h urine collections
Time Frame: 0 and 6 weeks
Untargeted metabolic profile of urine samples measured in all samples collected 24 hours before the intervention with beta glucans as well as in samples collected 6 weeks later 24 hours before study termination. The totality of the profiles is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA)
0 and 6 weeks
Metabolic profile in 3d fecal collections
Time Frame: 0 and 6 weeks
Untargeted metabolic profile of fecal samples measured in all samples collected 72-0 hours before the intervention with beta glucans as well as in samples collected 6 weeks later 72-0 hours before study termination. The totality of the profiles is used to explore for changes after baseline as detected by multivariate statistics (PLS-DA)
0 and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Lars Ove Dragsted, PhD, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2017

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

December 11, 2017

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 5, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After full anonymization the data may be shared pending acceptance by sponsor approximately 24 months after completion.

IPD Sharing Time Frame

24 months from completion

IPD Sharing Access Criteria

Full access to published, anonymized data

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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